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In this human factors study, 54 migraineurs used simulated injections to compare three sumatriptan subcutaneous delivery devices. Zembrace SymTouch, a two-step device, was most preferred compared with Sumavel DosePro and Imitrex STATdose. It also ranked highest for ease of use and various other measures. In this study, migraine patients preferred the autoinjector that they rated as simpler and more intuitive.
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Although the primary endpoint only just failed, the results of this pragmatic outcomes study demonstrate SNC to have benefits over its concomitantly administered components in the acute treatment of migraine.
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Sumatriptan (Imitrex), a selective 5-hydroxytryptamine receptor agonist, has been found to be of therapeutic benefit in the acute management of migraine. There is no information on the transfer of this agent across the human placenta. Accordingly, the current study assessed the transport of this drug across the normal term human placenta, using the isolated perfused single cotyledon technique. We found that only about 15% of a single dose of the agent placed in the maternal reservoir crossed into the fetal compartment over 4 hr. Given the average elimination half-life of 2 hr for sumatriptan, it is evident that only very small amounts of the agent will cross from mother to fetus after single doses of Imitrex. Only the parent drug entered the fetal compartment. Metabolites were not detected in the perfusates, but there was evidence of some metabolism of sumatriptan in the placenta. The nature of the metabolites has not been determined. The mechanism of transfer of the drug across the placenta is passive (i.e., the clearance is similar to L-glucose which is passively transported), the rate of transfer is equal in both directions (maternal to fetal and in the reverse), and the drug does not cross into the fetus against a concentration gradient. This passive transport of sumatriptan across the placenta is consistent with its molecular weight, its water solubility, and its slow penetration across the blood-brain barrier in experimental animals.
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Efficacy and tolerability profiles of Treximet [sumatriptan/naproxen sodium combination tablet (SNC)] have been established in clinical trials but have to date been virtually unstudied in pragmatic research. The primary objective of this study was to compare the overall satisfaction of SNC to its monotherapy components, S/N [one 100 mg Imitrex tablet (S) and two Aleve (naproxen sodium) 220 mg tablets, total dose 440 mg (N)] administered concomitantly using the Patient Perception of Migraine Questionnaire -Revised (PPMQ-R).
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To investigate whether the incidence of epithelial defects during laser in situ keratomileusis (LASIK) was different in patients who were taking sumatriptan (Imitrex, Glaxo Smith Kline, Pittsburgh, Pa) for migraine headaches than in those who were not.
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The migraine-specific triptans have revolutionized the treatment of migraine and are usually the drugs of choice to treat a migraine attack in progress. Sumatriptan (Imitrex) has been available for the longest time within the class, is most flexible in form and has been given successfully to the most number of patients. It is useful for the full range of attacks experienced by a migraine suffer. The aim of this review is to provide an overview of the first 10 years of the use of sumatriptan.
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The objective of this human factors study was to compare migraine patients' device use performance and preferences for three sumatriptan subcutaneous autoinjectors: a disposable two-step device (Zembrace(®) SymTouch(®)), a disposable three-step device (Sumavel(®) DosePro(®)), and a multistep reloadable device (Imitrex(®) STATdose(®)), using simulated injections.
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There is evidence that serotonin may be implicated in the pathophysiology of myofascial pain (MFP). Because of this, we used oral sumatriptan (Imitrex, Glaxo), a peripherally acting agonist of 5-HT1D receptors, in a double-blind, randomized, placebo-controlled double crossover pilot study of 7 patients with episodic MFP of the temporalis muscles. The results showed that there was a significant reduction in pain intensity and increase in pain relief over time with both the active medication and the placebo, but no significant difference between treatments. All but 1 patient reported that they are not interested in retaking the same medication. These data suggest that oral sumatriptan may not be the drug of choice in the control of episodic MFP.
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Each study subject performed two unaided simulated injections with each of three different drug delivery devices, which were presented in counterbalanced order. The participants were then asked to rate the three devices on various subjective measures. The primary end point was overall device preference using a visual analog scale.
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A total of 54 subjects participated and each subject performed two simulated injections with each of the three devices. Most subjects preferred the two-step device (88.9%) to the three-step (13.0%) and the reloadable (1.9%). The two-step device had higher mean overall preference ratings (F (2, 159)=56.6, P<0.01) and higher ratings for ease of use, intuitiveness, convenience, portability, and control. The two-step device had a first injection full-dose delivery success rate of 44.4%, higher than both the reloadable (24.1%) and the three-step (3.7%) devices. The number of errors with the two-step device (n=3) was ~90% lower than the three-step (n=49) and reloadable (n=44) devices.
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In the sumatriptan group, 11.1% (6 of 54) of eyes developed epithelial defects as compared to 9.3% (5 of 54) of eyes in the non-triptan group (P=.75, chi square). More recent sumatriptan exposure did not increase the incidence of epithelial defect (P=.47). In patients in whom sumatriptan was stopped >1 month prior to LASIK, 6.3% (1 of 16 eyes) had epithelial defects; in patients in whom sumatriptan was stopped <1 month prior to LASIK, 14.3% (4 of 28 eyes) developed epithelial defects; and 9.3% (5 of 54 eyes) of patients in whom no triptans had ever been used had epithelial defects (P=.70).
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Several strategies can reduce cost without sacrificing treatment outcome. In mild to moderate migraine, low-priced nonsteroidal anti-inflammatory drugs can be used as first-line medications due to their proven efficacy and favorable tolerability. For patients with more severe migraine, implementing a stratified care approach-using migraine-specific medications early in acute treatment-is cost-effective for most patients. Stratified care not only improves outcome and decreases disability, but also reduces cost. Pill splitting and early administration of triptans within an attack enhance their value. Supplying rescue medications, such as opioids, sedatives, and phenothiazines, can prevent emergency department visits. Minimizing multiple dosing of triptans and reducing utilization of expensive health care resources are key factors in reducing the cost of effective migraine treatment. An important affordability factor for patients with co-payments is the number of triptan pills per package. Sumatriptan, naratriptan, and frovatriptan each contain 9 tablets per package, while most other triptan packages contain 6. Current triptan retail prices (per unit) include: Amerge 1 and 2.5 mg, 17.78 dollars; Axert 6.25 and 12.5 mg, 16.31 dollars; Frova 2.5 mg, 13.89 dollars; Imitrex 50 mg, 14.96 dollars; Imitrex 100 mg, 14.41 dollars; Imitrex Nasal Spray 20 mg, 21.61 dollars; Imitrex SQ 6 mg, 50.26 dollars; Maxalt 5 and 10 mg, 15 dollars; Maxalt-MLT 5 and 10 mg, 15 dollars; Relpax 40 mg, 13.58 dollars; Zomig 2.5 mg, 13.67 dollars; Zomig 5 mg, 15.89 dollars; Zomig-ZMT 2.5 mg, 13.67 dollars; and Zomig-ZMT 5 mg, 15.89 dollars.
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For administration sites in the thigh and the abdomen, but not the arm, the needle-free and needle-based systems were bioequivalent (for all pharmacokinetic endpoints the mean ratios between the 2 devices were always between 90.1% and 115%). Among outpatients treating a migraine attack with the needle-free system, 51 of 52 on first attempt used the needle-free system successfully when treating a migraine attack.
The efficacy and tolerability of subcutaneous (SC) sumatriptan administered with the IMITREX (sumatriptan succinate) STATdose System, which circumvents the need for patients or health care professionals to handle a syringe, were evaluated in two randomized, double-masked, parallel-group, placebo-controlled, multicenter studies. In the clinic, 158 adults with migraine diagnosed according to International Headache Society criteria received SC sumatriptan (6 mg) or placebo delivered with the IMITREX STATdose System for treatment of a migraine attack. By 120 minutes after SC dosing, 73% and 79% of sumatriptan-treated patients, compared with 28% and 37% of placebo-treated patients in studies 1 and 2, respectively, experienced headache relief (a statistically significant difference). Clinical disability scores 120 minutes after dosing showed that 75% and 85% of sumatriptan-treated patients, compared with 30% and 42% of placebo-treated patients, were normal or only mildly impaired (a statistically significant difference). Similar efficacy rates were observed for nausea, phonophobia, and photophobia. No serious or unusual adverse events occurred, and no clinically relevant abnormalities in laboratory test values were reported. Based on these results, we concluded that SC sumatriptan (6 mg) administered using the IMITREX STATdose System is effective for the treatment of migraine. The efficacy and tolerability profiles of SC sumatriptan administered with this device are similar to those reported for SC sumatriptan administered with a conventional syringe.
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Factors such as body size (weight and body mass index [BMI]), age, sex, and race might influence the clinical response to sumatriptan. We evaluated the impact of these covariates on the plasma concentration (Cp) profile of sumatriptan administered subcutaneously.
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Clinics and private neurology practices.
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Sumatriptan succinate (SS) is a selective serotonin receptor agonist used for the treatment of migraine attacks, suffering from extensive first-pass metabolism and low oral bioavailability (∼14%). The aim of this work is to compare the performance of different ready-made co-processed platforms (Pharmaburst®, Prosolv ODT®, Starlac®, Pearlitol Flash®, or Ludiflash®) in the formulation of SS sublingual orodispersible tablets (ODTs) using direct compression technique. The prepared SS ODT formulae were evaluated regarding hardness, friability, simulated wetting time, and in vitro disintegration and dissolution tests. Different mucoadhesive polymers-HPMC K4M, Carbopol®, chitosan, or Polyox®-were tested aiming to increase the residence time in the sublingual area. A pharmacokinetic study on healthy human volunteers was performed, using LC/MS/MS assay, to compare the optimum sublingual formula (Ph25/HPMC) with the conventional oral tablet Imitrex®. Results showed that tablets prepared using Pharmaburst® had significantly (p < 0.05) the lowest simulated wetting and in vitro disintegration times of 17.17 and 23.50 s, respectively, with Q 5 min of 83.62%. HPMC showed a significant (p < 0.05) increase in the residence time from 48.44 to 183.76 s. The relative bioavailability was found to be equal to 132.34% relative to the oral tablet Imitrex®. In conclusion, Pharmaburst® was chosen as the optimum ready-made co-processed platform that can be successfully used in the preparation of SS sublingual tablets for the rapid relief of migraine attacks.
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Relief of head pain and recurrence of successfully treated headache.
In healthy subjects, DFN-02, an intranasal spray containing 10 mg sumatriptan plus DDM, had a more rapid absorption profile than commercially available intranasal sumatriptan 20 mg, and systemic exposure from a single-dose administration of DFN-02 was similar to 4 mg SC sumatriptan and two-thirds that of 6 mg SC sumatriptan. With DFN-02, plasma sumatriptan peaked 5 minutes earlier than with both subcutaneous formulations. Systemic exposure to sumatriptan was similar with DFN-02 and 4 mg subcutaneous sumatriptan; both yielded lower systemic exposure than 6 mg subcutaneous sumatriptan. Systemic exposure to DFN-02's excipient DDM was short-lived. DFN-02's safety and tolerability appear to be comparable to subcutaneous sumatriptan. Addition of a permeation enhancer improved the absorption profile compared with commercially available intranasal sumatriptan 20 mg.
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Adults with migraine (n = 50) without 'medication overuse headache' were treated for up to 18 migraine attacks per 3-month study period with study medication; SNC during one study period and S/N during the other study period. For all endpoints, differences between treatments were compared with paired t tests.
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Subcutaneous (s.c.) injection of sumatriptan is currently associated with needle aversion in some patients, and sharps disposal issues.
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Sumatriptan succinate (Imitrex) is a 5-HT (5-hydroxytryptamine) agonist used for relief of migraine symptoms. Some individuals experience short-lived side-effects, including heaviness of the limbs, chest heaviness and muscle aches and pains. The effects of this drug on skeletal muscle energy metabolism were studied during short submaximal isometric exercises. We studied ATP flux from anaerobic glycolysis (An Gly), the creatine kinase reaction (CK) and oxidative phosphorylation (Ox Phos) using 31P nuclear magnetic resonance spectroscopy (31P MRS) kinetic data collected during exercise. It was found that side-effects induced acutely by injection of 6 mg sumatriptan succinate s.c. were associated with reduced oxygen storage in peripheral skeletal muscle 5-20 min after injection as demonstrated by a transient reduction in mitochondrial function at end-exercise. These results suggest that mild vasoconstriction in peripheral skeletal muscle is associated with the action of sumatriptan and is likely to be the source of the side-effects experienced by some users. Migraine with aura patients were more susceptible to this effect than migraine without aura patients.
To provide medication price data and cost-reducing strategies for the acute treatment of migraine.
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A retrospective chart review was performed on 54 eyes of 28 patients who had been identified as taking sumatriptan and had undergone LASIK at Minnesota Eye Consultants between 1999 and 2001. These patients were compared with 54 gender- and age-matched control eyes operated on with the same microkeratome at the same location during the same period of time. The incidence of epithelial defects during LASIK was compared between the two groups.
This randomized, double-blind, parallel-group, placebo-controlled study evaluated the efficacy and tolerability of oral sumatriptan (Imitrex tablets) in 259 migraineurs. In the clinic, patients received oral sumatriptan 25 mg, 50 mg, or 100 mg, or placebo for the treatment of a migraine attack. The results indicate that by 2 hours post-dose, 50 to 56% of patients treated with any of the three doses, compared with 26% of patients treated with placebo, achieved relief of headache (p < 0.05 for each sumatriptan group vs placebo). By 4 hours postdose, 68 to 71% of sumatriptan-treated patients, compared with 38% of placebo-treated patients, achieved relief of headache (p < 0.05 for each sumatriptan group vs placebo). Oral sumatriptan was similarly effective at relieving nausea and photophobia and at reducing clinical disability. The pattern and incidence of adverse events did not differ between treatment groups. All doses--25 mg, 50 mg, and 100 mg--of sumatriptan were effective and generally well tolerated. Dosing should be individualized according to the needs of the patient.
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Sumatriptan succinate (SS) is a 5-HT1 receptor agonist used in the treatment of migraine having poor bioavailability (15%) due to its extensive first-pass effect. The aim of this work was to prepare SS sublingual fast dissolving thin films (SFDTFs) allowing the drug to directly enter the systemic circulation and bypassing the first-pass metabolism. Plain thin films were prepared using solvent casting technique adopting 2(3) × 3 factorial design to study the effect of polymer and plasticizer type and concentration on mechanical properties and in vitro disintegration time of the plain prepared films using Design-Expert®. Medicated films were prepared after addition of 35 mg SS to each of the two selected plain formulae (F6 and F7) having desirability values above 0.9 showing the values of: 0.038, 0.039 kgf/mm(2) and 156.24, 164.16% and 0.0248, 0.0240 kgf/mm(2) as tensile strength, percent elongation and elastic modulus, respectively. PVP K30 was efficient as crystallization inhibitor in retarding SS crystallization. Pharmacokinetic study of the optimum formula F7 (PVP K30:SS (1:1 w/w)) in healthy human volunteers using LC/MS/MS revealed a shorter tmax (0.25 h) compared to Imitrex® tablet 25 mg (2 h) which is considered promising especially for the rapid relief of acute migraine attacks.
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Double-blind, randomized trial with parallel treatment arms.